Individual applicants may not submit more than one NIBIB
P30 Center application. However, there is no limit on the number of
applications an institution may submit provided that each application is
scientifically distinct. See Section
III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.286

Funding Opportunity Purpose

NIBIB will establish Biomedical Technology Service Centers
(P30 Centers) that support infrastructure and resources that are needed by a
diverse group of funded NIH researchers, but are not widely available.
Consistent with this function NIBIB P30 Centers should engage in dissemination
activities and may engage in training activities. Infrastructure and
resources in an NIBIB P30 Center could range from shared biomedical
instrumentation to open bioinformatics systems.

It is critical that applicants follow the instructions in
the PHS 398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all
grant programs to electronic submission using the SF424 Research and Related
(R&R) format and is currently investigating solutions that will accommodate
NIH’s multi-project programs. NIH will announce plans to transition the
remaining programs in the NIH
Guide to Grants and Contractsand on NIH’s Applying Electronically website.

NIBIB-supported Biomedical Technology Service Centers
(NIBIB P30 Centers) ensure that independently-funded NIH investigators working
in a targeted area will have access to biomedical technologies and expertise
that are not widely available.

NIBIB P30 Centers must serve
investigators from multiple institutions outside the applicant institution and
are expected to be regional or national in scope.

Resources available in a
typical NIBIB P30 Center could include, but are not limited to, specialized
shared instrumentation, customized algorithms, novel tissue/organ engineering
platforms or open bioinformatics systems.

NIBIB P30 Centers will not
support independent scientific research or unfunded pilot studies, except for
limited development of novel technologies that support the NIBIB P30 Center service
mission (see "Technology Service Cores" section).

NIBIB will not support P30
Centers that focus on a specific disease, and will not support P30 Centers that
involve clinical trials or patient services.

NIBIB will not support P30
Centers that overlap with pre-existing facilities at the host institution.

Consistent with their
function to help the community gain access to these resources, NIBIB P30
Centers should engage in dissemination activities.

If appropriate, NIBIB P30
Centers may also engage in training activities.

NIBIB P30 Centers shall consist
of one Administrative Core and one or more Technology Service Cores.

The Administrative Core
coordinates the different components and activities of the NIBIB P30 Center
including training and dissemination, etc.

Technology Service Cores are
shared facilities that provide a needed service to investigators outside of the
NIBIB P30 Center, enabling them to conduct their funded individual research
projects more effectively.

Each Technology Service Core shall
have an associated Research Base component consisting of projects that will
utilize the Technology Service Core. Investigators using the Technology Service
Cores (i.e., the "Research Base") are expected to have
highly-regarded existing biomedical research programs funded by NIH Institutes
or Centers, other Federal Agencies, or other nationally or
internationally-recognized funding sources.

NIBIB P30 Centers have an External Advisory Committee (EAC)
that advises the Program Director/Principal Investigator on current operating
procedures and future directions for the NIBIB P30 Center.

Because extensive planning is required in preparing NIBIB P30
applications, prospective new applicants are encouraged to discuss their plans
with the relevant NIBIB Program Directors (refer to http://www.nibib.nih.gov/Research/ProgramAreas)
well before the application is prepared.

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER
Glossary and the PHS 398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

The number of awards will depend on NIH appropriations and
the submission of a sufficient number of meritorious applications. On
average, NIBIB anticipates funding approximately one new application every
one or two years.

Award Budget

Application budgets are not limited but it is strongly
recommended that applicants not request a budget of more than $600,000 in
direct costs per year. In addition, up to $500,000 can be requested for
equipment over the five-year duration of the grant.

Award Project Period

Support may be requested for up to five years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are noteligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS 398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Multiple PDs/PIs are not allowed. Only one PD/PI may be designated
on the application. The PD/PI may not submit more than one NIBIB P30 Center
application.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application
and Submission Information

1. Address to Request
Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the PHS 398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1.
Overview Information, prospective applicants are asked to submit a letter
of intent that includes the following information:

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations described in the PHS 398 Application
Guide and the Table of
Page Limits must be followed, in addition to the following page limitations
to the Research Strategy section of each component of the application.

Overall: 12 pages

Administrative Core: 6 pages

Technology Service Core (s): 12 pages each

Dissemination Core: 6 pages

Training Core: 6 pages

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in
the PHS398 Application Guide, and should be used for preparing a
multi-component application.

The application should consist of the following components:

Overall Component

Administrative Core

Technology Service Core (s)

Dissemination Core

Training Core: optional

Overall Component

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions, as noted.

All instructions in the PHS 398 Application Guide
must be followed. The Table of Contents for the Overall Component should
include all Components in this application.

Detailed Budget for Initial Budget
Period (Overall)

All instructions in the PHS 398 Application Guide
must be followed with the following additional instructions: Estimated Initial
Budgets for all Components should be included in the estimated Initial Overall
Budget.

Budget for Entire Proposed Period of
Support (Overall)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions: Estimated Entire
Budgets for all Components should be included in the estimated Entire Overall
Budget.

Funds may be requested for professional personnel,
technical and support personnel, equipment, supplies, travel, consultants
and web site development. Allowable items for each category are given below:

Professional
Personnel: Salaries for Key personnel. The PD/PI is expected
to devote at least 3 calendar months of his/her efforts to the P30 Center,
with a minimum of 1.2 calendar months being devoted to the Administrative
Core. The P30 Center can cover salaries for individual Technology Service Core
Component Directors to the extent that they provide an essential P30 Center
function. No overlap of time or effort between the P30 Center and other funded
projects is permitted.

Technical
and Support Personnel: Salaries for technical or support
positions in the P30 Center. No overlap of time or effort between the P30
Center and other funded grants is permitted.

Equipment: Major equipment requests should be justified. Price quotes should be included
for equipment costing more than $25,000. General purpose equipment requests
should be included only when necessary to support visiting P30 Center
investigators.

Consortium/Contractual
agreements: Funds may be requested for domestic subcontracts.
In general, funds may not be requested for foreign subcontracts. Foreign
subcontracts may be allowed if a written waiver is provided by the NIBIB
Associate Director.

Note: Funds may not be requested to support courses
given for academic or other types of credit. Individuals benefiting from the
training programs may not be paid a stipend.

Note: Funds may not be requested for alteration and
renovation, rental space, staff retreats, direct support for individual
research projects, or direct support for pilot studies.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide
must be followed. Start with a Biographical Sketch of the PD/PI, followed by Biographical
Sketches of other investigators arranged in alphabetical order.

This section should contain all relevant Biographical
Sketches for the entire application.

Resources (Overall)

All instructions in the PHS 398 Application Guide
must be followed. Describe the institutional commitment to the P30 Center
(e.g., laboratory/office space, facilities, research funds).

Research Plan (Overall)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Research
Strategy: NIBIB P30 Centers shall consist of one Administrative
Core and one or more Technology Service Cores.

Describe the overall objectives of the P30 Center,
and discuss what makes this particular P30 Center unique.

Give a brief overview of the Technology Service
Cores, and evaluate the regional and national need for the Technology Service
Cores.

Describe the qualifications of the PD/PI. He/she should
be a highly experienced and respected scientist with demonstrated
administrative capabilities and a proven track record for obtaining NIH and/or other
relevant funding, as well as a track record of providing technical service to
the scientific community. Only one PD/PI may be designated for a P30 Center.

For New Applications, describe the factors and events
contributing to the decision to create the P30 Center.

For Renewal Applications, highlight major
accomplishments from the previous funding period, and point out major changes
from the original P30 Center design.

Researchers are encouraged to share data obtained using
the facilities of the P30 Center. Scientific and technical staff are
encouraged to share information on the technologies available at the P30
Center.

Administrative Core

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

A Title page with the name of the Core and the Core
Director should be generated in place of the Face Page.

This section should contain the Table of Contents for
the Administrative Core. The Table of Contents for the entire application should
be presented in the Table of Contents section of the Overall Component.

Detailed Budget for Initial Budget
Period (Administrative Core)

This section should contain the Detailed Initial
Budget for the Administrative Core.

Budget for Entire Proposed Period of
Support (Administrative Core)

This section should contain the Entire Budget for the
Administrative Core.

Biographical Sketch (Administrative
Core)

All relevant Biographical Sketches should be
presented in the Biographical Sketch section of the Overall Component.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Specific
Aims: State concisely the goals of the proposed Administrative
Core.

Research
Strategy: The PD/PI of the P30 Center will be the Director of
the Administrative Core.

Describe the qualifications of other staff who will
be involved in the Administrative Core.

The External Advisory Committee is appointed by the PD/PI.
External Advisory Committee members and the chair should be from outside the
host institution, and should be rotated periodically.

Describe the role of the External Advisory
Committee. The External Advisory Committee chair should be knowledgeable about
the P30 Center technology and the science it serves, but should not be a member
of the P30 Center staff or a major user of the P30 Center. Other committee
members should be balanced among scientists knowledgeable about the P30 Center
technologies, experts in the application of P30 Center technologies to
biomedical research problems, and users of the technology.

For new P30 grant applications the External Advisory
Committee should not be constituted prior to or during the review of the
application, and potential candidates should not be approached or discussed.

For existing P30 Centers, list the current members of
the External Advisory Committee, and briefly describe their qualifications.

The External Advisory Committee should meet at least
annually and prepare a written report, addressed to the PD/PI, of its
recommendations. This report must be supplied as part of the P30 Center Annual
Progress Report.

Describe the role of any local executive committees
that are proposed as adjuncts to the External Advisory Committee.

Describe the P30 Center organizational structure.
Discuss the relationship of the P30 Center to the administrative structure of
the grantee institution.

Describe the P30 Center operating procedures.
Discuss procedures to review requests for use of the equipment and facilities,
and to schedule use.

Researchers are encouraged to share data obtained using
the facilities of the P30 Center. Scientific and technical staff are
encouraged to share information on the technologies available at the P30
Center.

Technology Service Core(s)

All instructions in the PHS398 Application Guide must be
followed. NIBIB P30 Centers do not have a minimum number of Technology Service
Cores. However, if there is more than one Technology Service Core, each
Technology Service Core should be considered as a separate Component and
described separately.

Face Page (Technology Service Core)

A Title page with the name of the Core and the Core Director
should be generated in place of the Face Page.

This section should contain the Table of Contents for
the Technology Service Core. The Table of Contents for the entire application
should be presented in the Table of Contents section of the Overall Component.

Detailed Budget for Initial Budget Period
(Technology Service Core)

This section should contain the Detailed Initial
Budget for the Technology Service Core.

Budget for Entire Proposed Period of
Support (Technology Service Core)

This section should contain the Entire budget for the
Technology Service Core.

Biographical Sketch (Technology
Service Core)

All relevant Biographical Sketches should be
presented in the Biographical Sketch section of the Overall Component.

Resources (Technology Service Core)

All instructions in the PHS 398 Application Guide should
be followed.

Research Plan (Technology Service
Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Specific
Aims: State concisely the goals of the proposed Technology
Service Core. .

Research
Strategy: Identify the Director of each Technology Service
Core, and discuss his/her qualifications. Technology Service Core Directors
should be acknowledged experts with independently-funded research programs that
use the Technology Service Core services. The PD/PI of the P30 Center may be
Director of one (or more) of the Technology Service Cores.

The Technology Service Cores may support technicians
and engineers that have the appropriate scientific or engineering skills.
Examples of appropriate skills could be: operation and maintenance of the
specialized shared instrumentation, development of custom algorithms,
development of tissue/organ bioengineering platforms and development of open
bioinformatics systems. Where appropriate, an established expert in the
Technical Service Core activities could also be included as a consultant.

Describe the hardware, software and other specialized
facilities available to the Technology Service Core. Technology Service Cores
are expected to implement and maintain appropriate commercial equipment and
off-the-shelf software, and may also utilize specially-designed equipment and
software. Finally, limited developmental research is appropriate if it
directly enhances the utility of the Technology Service Cores. Whenever
possible, open-source software should be utilized. If an element of the
support provided by the P30 Center involves software or algorithm development,
it should be disseminated in open-source platforms.

Discuss the investigator usage of each Technology
Service Core. The minimum requirement for establishing a Technology Service
Core is significant usage by five or more investigators with
independently-funded, peer-reviewed projects. The resources in the Technology
Service Cores should be equitably distributed: the maximum effort that a single
Technology Service Core can spend on projects directed by a single investigator
is 25%.

Projects using a particular Technology Service Core
form a "Research Base" for that Technology Service Core. Each
Research Base must be described in detail in the Appendix.

For New Applications, each Technology Service Core
should include information on preliminary studies.

For Renewal Applications, each Technology Service
Core should include a Progress Report.

Researchers are encouraged to share data obtained using
the facilities of the P30 Center. Scientific and technical staff are
encouraged to share information on the technologies available at the P30
Center.

Dissemination Core

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions, as noted:

Face Page (Dissemination Core)

A Title page with the name of the Core and the Core Director
should be generated in place of the Face Page.

This section should contain the Table of Contents for
the Dissemination Core. The Table of Contents for the entire application
should be presented in the Table of Contents section of the Overall Component.

Detailed Budget for Initial Budget
Period (Dissemination Core)

This section should contain the Detailed Initial
Budget for the Dissemination Core.

Budget for Entire Proposed Period of
Support (Dissemination Core)

This section should contain the Entire Budget for the
Dissemination Core.

Biographical Sketch (Dissemination Core)

All relevant Biographical Sketches should be presented
in the Biographical Sketch section of the Overall Component.

Resources (Dissemination Core)

All instructions in the PHS 398 Application Guide
should be followed.

Research Plan (Dissemination Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Specific
Aims: State concisely the goals of the proposed Dissemination

Research
Strategy: A fundamental motivation for the NIBIB P30 Center
program is to apply cutting-edge technology to important biomedical research
problems. The realization of this goal depends on an effective Dissemination
Program.

Describe the details of the Dissemination Program.
Dissemination activities should inform the scientific community about the
technical capabilities of the P30 Center, and promote and enable a broader use
of the technologies.

A variety of approaches can be proposed to promote
dissemination. These approaches include, but are not limited to: publishing
book chapters, patents, newsletters, or annual reports; conducting workshops;
distributing software products; transferring technologies to other
laboratories; licensing technologies to industry; and building a robust web
presence.

Researchers are encouraged to share data obtained using
the facilities of the P30 Center. Scientific and technical staff are
encouraged to share information on the technologies available at the P30
Center.

Training Core (optional)

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions, as noted:

Face Page (Training Core)

A Title page with the name of the Core and the Core Director
should be generated in place of the Face Page.

Research
Strategy: The Training Program (if present and appropriate for
the P30 Center) should create a cadre of biomedical researchers that are
trained in the P30 Center technologies, and can effectively apply them to their
own research. The academic rank of the trainees should be appropriate to the
technology being disseminated, and could range from advanced graduate students,
who are using the technology in their thesis projects, to faculty members and
practicing physicians, who are aiming to use the technology in their research
and/or clinical practice.

Researchers are encouraged to share data obtained using
the facilities of the P30 Center. Scientific and technical staff are
encouraged to share information on the technologies available at the P30
Center.

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS 398 Application Guide.

For each Technology Service Core include a Research Base in
the Appendix. Describe up to 12 projects in each Research Base in detail (up
to one page for each project). In addition, provide a Table that includes each
project in the Research Base. Each entry in the Table should include:

Project title

Name of the PD/PI

PD/PI institution

Details of peer reviewed funding(s)

Start and end dates for the project(s)

Number of publications that have resulted from the project (for
Renewal applications only)

Utilization of human subjects or animals in the project (Yes/No)

For Renewal applications, projects from the previous funding
period that are not being continued should be listed in a separate Table.

For Renewal applications, the Appendix should also include the
most recent External Advisory Committee Report.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any
year.

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIBIB program staff at
least 6 weeks before submitting the application and follow the Policy on the
Acceptance for Review of Unsolicited Applications that Request $500,000 or More
in Direct Costs as described in the PHS Application Guide. This policy applies
to all New, Renewal and Resubmission applications.

Post-Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the P30 Center to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
P30 Center proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a P30 Center that by its nature is
not innovative may be essential to advance a field.

Significance

Does the P30 Center address an important problem or a
critical barrier to progress in the field? If the aims of the P30 Center are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Additional review criteria for NIBIB P30 Centers:
Will the P30 Center have a significant influence on the biomedical research
output of the funded investigators in the Research Base in ways that would not
be practical for individual research projects?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the P30 Center? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Additional review criteria for NIBIB P30 Centers: Is
the PD/PI well qualified to effectively administer the P30 Center? Are the PD/PI,
the Technology Service Core Directors and personnel appropriately trained for
their respective roles? Are they able to devote adequate effort to the P30
Center activities? Do they have a history of performing services for their
colleagues or the scientific community at large, outside of the needs of their
own research?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

For NIBIB P30 Centers "Innovation" is
defined as a coherent plan to ensure that independently-funded NIH
investigators have access to biomedical technologies and expertise that are not
widely available, but will substantially increase the productivity and the
impact of the NIH-funded research.

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the P30 Center?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the P30 Center involves clinical research, are the plans for 1) protection
of human subjects from research risks, and 2) inclusion of minorities and
members of both sexes/genders, as well as the inclusion of children, justified
in terms of the scientific goals and research strategy proposed?

Additional review criteria for NIBIB P30 Centers: Do
the Technology Service Cores provide advanced technologies and services that
are not easily available to investigators in the Research Base? Are they
appropriate for the anticipated research needs of PD/PIs in the Research Base?
Are plans for the administration of the P30 Center appropriate? Does the
Dissemination Plan assure that the facilities and service will be widely used,
with easy and fair access to appropriate users?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional review criteria for NIBIB P30 Centers: Do
the PD/PIs using the Technology Service Cores (i.e., the Research Base) have
highly-regarded existing biomedical research programs funded by NIH Institutes
or Centers, other Federal Agencies, or other nationally or
internationally-recognized funding sources?

Additional Review Criteria - Overall

As applicable for the P30 Center proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human Subjects
Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable

Training Plan

Where the Training Plan is in place, does it ensure
that a cadre of trained biomedical Researchers can apply the P30 Center
technologies effectively in their own research?

Additional Review Considerations - Overall

As applicable for the P30 Center proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall
impact score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center and will compete
for available funds with all other recommended applications. Following initial
peer review, recommended applications will receive a second level of review by
the National Advisory Council of the NIBIB. The following will be considered in
making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.